MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number	ZA9003
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth, weight and ethnicity: information unknown/not provided.If implanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a tecnis intraocular lens (iol) haptic was bent/broken while inserting into the patient's right (od) eye.The lens was removed and the patient has recovered.The outcome did not significantly interfere with activities of daily life.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer: yes.Section d9: date returned to manufacturer: sep 27, 2021.Section h3: device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the lens was received cut and viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during removal and replacement.A detached haptic and a damaged haptic (bent) were also observed.The complaint issue was confirmed; however, based on the return condition of the lens it cannot be confirmed to be related to manufacturing, and therefore, no product deficiency could be identified.Manufacturing records review: the manufacturing records review was performed, and no nonconformity report was found as part of this manufacturing records review.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12449384
• Report Number: 2020664-2021-07310
• Device Sequence Number: 11661151
• Product Code: HQL
• UDI-Device Identifier: 05050474528895
• UDI-Public: (01)05050474528895(17)220608
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2022
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1